BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPO GUIDE CATHETER

    MDR report key: 2032793 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-01262
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQO
    PMA / PMN Number
    K992142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A 29 MM SECTION OF WHITE POLYURETHANE, CONSISTENT WITH A LENGTH OF THE INNER LINING OF THE DEVICE. VISUAL AND MICROSCOPIC ANALYSIS REVEALED BLOOD ON THE LINING AND THE ENDS WERE JAGGED. THERE WERE SEVERAL SMALL HOLES IN THE LINING AND THE ENTIRE LENGTH WAS IMPRINTED WITH A BRAID PATTERN FROM THE OUTER BRAIDED SHAFT OF THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE, FOREIGN MATERIAL WAS NOTED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.5 5F NON BSC GUIDE WIRE AND A LEFT EXPO DIAGNOSTIC CATHETER WERE SUCCESSFULLY ADVANCED AND USED DURING THE PROCEDURE WITH NO ISSUES. NEXT, A 5F EXPO DIAGNOSTIC GUIDE CATHETER WAS SELECTED AND WHILE ADVANCING THROUGH A 5F NON BSC INTRODUCER SHEATH RESISTANCE WAS ENCOUNTERED. ONCE THE DISTAL SECTION OF THE NON BSC GUIDE WIRE WAS REACHED MORE RESISTANCE WAS ENCOUNTERED AND THE EXPO DIAGNOSTIC CATHETER WOULD NOT ADVANCE ANY FURTHER. AS A RESULT BOTH THE NON BSC GUIDE WIRE AND THE EXPO DIAGNOSTIC CATHETER WERE REMOVED TOGETHER AS ONE UNIT. A NON BSC INTRODUCER SHEATH MAINTAINED ACCESS AND THE CASE WAS COMPLETED WITH A NON BSC RIGHT CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK. AFTER THE DEVICES WAS REMOVED FROM THE PATIENT'S ANATOMY THE EXPO DIAGNOSTIC CATHETER WAS CUT BY THE PHYSICIAN TO DETERMINE WHY RESISTANCE WAS ENCOUNTERED. THE NON BSC GUIDE WIRE WAS REMOVED FROM THE CATHETER LUMEN AND A WHITE BRAIDED MATERIAL WAS DISCOVERED BLOCKING THE DISTAL LUMEN OF THE EXPO DIAGNOSTIC CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE, FOREIGN MATERIAL WAS NOTED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.5 5F NON BSC GUIDE WIRE AND A LEFT EXPO DIAGNOSTIC CATHETER WERE SUCCESSFULLY ADVANCED AND USED DURING THE PROCEDURE WITH NO ISSUES. NEXT, A 5F EXPO DIAGNOSTIC GUIDE CATHETER WAS SELECTED AND WHILE ADVANCING THROUGH A 5F NON BSC INTRODUCER SHEATH RESISTANCE WAS ENCOUNTERED. ONCE THE DISTAL SECTION OF THE NON BSC GUIDE WIRE WAS REACHED MORE RESISTANCE WAS ENCOUNTERED AND THE EXPO DIAGNOSTIC CATHETER WOULD NOT ADVANCE ANY FURTHER. AS A RESULT BOTH THE NON BSC GUIDE WIRE AND THE EXPO DIAGNOSTIC CATHETER WERE REMOVED TOGETHER AS ONE UNIT. A NON BSC INTRODUCER SHEATH MAINTAINED ACCESS AND THE CASE WAS COMPLETED WITH A NON BSC RIGHT CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK. AFTER THE DEVICES WAS REMOVED FROM THE PATIENT'S ANATOMY THE EXPO DIAGNOSTIC CATHETER WAS CUT BY THE PHYSICIAN TO DETERMINE WHY RESISTANCE WAS ENCOUNTERED. THE NON BSC GUIDE WIRE WAS REMOVED FROM THE CATHETER LUMEN AND A WHITE BRAIDED MATERIAL WAS DISCOVERED BLOCKING THE DISTAL LUMEN OF THE EXPO DIAGNOSTIC CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPO GUIDE CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - MAPLE GROVE H749085263011

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR INTRODUCER SHEATH, TERUMO 5F| GUIDE WIRE, 3.5 MEDTRONIC 5F| DIAGNOSITIC CATHETER, EXPO